Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

June 11, 2020

Primary Completion Date

March 2, 2024

Study Completion Date

March 2, 2024

Conditions
Gastric AdenocarcinomaCancer MetastaticChemotherapy Effect
Interventions
DRUG

Pressurized intraperitoneal aerosol chemotherapy (PIPAC)

After insufflation of a 12 mmHg of capnoperitoneum at 37°C, two balloons safety trocars (10 and 12mm) are inserted into the abdominal wall. Injection of Doxorubicin (2.1 mg/m2 in 50 ml NaCl 0.9%) and Cisplatin (10.5 mg/m2 body surface in 150 ml NaCl 0.9%) with a flow rate of 0.7ml/s, the therapeutic capnoperitoneum is maintained for 30 min at body temperature.

DRUG

Standard chemotherapy

Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.

Trial Locations (1)

59000

Hôpital Universitaire Claude Huriez, Lille

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT04065139 - Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study | Biotech Hunter | Biotech Hunter